1. Field of the Invention
The invention relates generally to a flexible analog/digital configuration, the system being preferably on a chip, and used for receiving various inputs, processing them, and being able to display/communicate the results and/or provide a response thereto. The invention also relates to a user-configurable instrument designed as a system on a chip (SoC) or as a stand-alone, handheld, user-wearable, or implantable device with functionality defined through a Graphical User Interface (GUI) or other methodology.
The invention also relates to analysis methods and equipment, and in particular to measurement, diagnostic, and treatment equipment able to perform any or all of the functions substantially simultaneously or in a prescribed order. It allows not only for immediate testing but also for long term monitoring of a disease, and for treatment in response to such monitoring, as well as for monitoring of treatment efficacy, which can have importance both for personalized medicine and for drug discovery.
2. Status of Prior Art
The medical device field for measurement, analysis, and treatment of the human (and non-human) condition has grown substantially over the past years as the ability to build customized equipment, easily and quickly using specialized chips, has enabled both large and small companies to enter the field. Of particular interest has been the use of so-called “biomarkers”, each of which can be defined to represent a specific measurement or series of measurements, representative of a specific condition or function of the biological system. Other measurements of parameters such as blood gases (e.g., pO2, pCO2), pH, electrolytes, temperature, measured bodily electrical signals (e.g., EKG, EEG, EMG), etc are often made independently of biomarker measurements.
Biomarkers may be associated with a particular disease, or with a range of diseases, or alternatively with a series of predefined biomarkers as dictated by the user. Methods such as genomics, proteomics, and/or molecular imaging, among other methods, can be used in the generation of the biomarker information. Among specific methods used, a variety of spectroscopic methods can be applied, such as fluorescent spectroscopy and mass spectroscopy, which can be used, e.g., for gene expression profiling, Raman spectroscopy and lately Fourier transform infrared spectroscopy (FTIR).
Substantial quantities of data relating to biomarkers and other parameters regarding the human condition such as blood gases, pH, electrolytes, temperature, electrical signals and the like, have been collected for many specific diseases of the body. Also automatic test equipment has been marketed and has been, typically, measurement driven. Equipment is available for measuring pH, oxygen, and temperature at various parts of the body, and various biological measurement schema which are intended to measure, for example, sugar levels, blood counts, the presence of various genes, proteins, acids, etc., and so on are also available. Such equipment is available from many different vendors and provides in many cases, excellent results for the measurement for which they were designed. It is then, typically, up to the doctor or an automated analysis device, which is used by the lab or the doctor and into which selected data is provided, as requested by the doctor, to provide a diagnosis of the patient.
Similar advances are being made in connection with non-human measurement and analysis, as well as in the measurement and analysis of environmental “parameters” (for example, quality of water) in an effort to improve and automate the analysis and resulting diagnosis and conclusions relating to the input data.
Semiconductor manufacturing technology has progressed substantially to allow more custom definitions of systems on a single chip. Nevertheless, researchers in many fields, including, without limitation, biological and medical sciences, and physiotherapy, and clinicians who make use of electrical stimulators and sensors for activities in which they engage, seek further instrumentation which enables them to treat patients with specialized and customizable equipment, but at a reasonable cost, in conformance, for example, with established industry guidelines. Such equipment, while often available at high price and for specialized purposes, often does not meet the needs of these workers. As a result, those working in these and other fields of endeavor are limited in their ability to quickly react to and provide for either patient use or experimental use systems meeting their needs. Further, by “patient”, we mean, as used in its broadest sense, human and non-human mammals and other animals, as well as plants (i.e. multicellular organisms), tissues and cells (aggregate and single cells).
Accordingly, it is desirable to find a method and apparatus to enable such workers to quickly generate and use systems meeting their electrical stimulation and input receiving needs without undue delay or cost. In addition, such systems need to be able to be produced as both one of a kind systems, as well as in production quantities in order to satisfy current needs.